BRPI0806361B1 - DEVICE TO CONTROL HEMORRAGY IN A PATIENT'S BODY CAVITY, USE AT LEAST AN EXPANSIBLE BALLOON MANUFACTURING A DEVICE AND KIT - Google Patents

Description

Field of the Invention The present invention relates generally to the field of medicine and, more particularly, to a balloon-buffering device. and to methods for control of bleeding in a body cavity.

Background of the Invention The pelvis is the bony structure located at the base of the spine. Each iliac bone (hip bone) consists of three bones: the ilium, the ischium and the pubis. The two iliac bones are joined anteriorly at the pubic symphysis and posteriorly at the sacrum. The pelvis incorporates the socket part of the hip joint for each leg and forms the waistlines of the lower skeleton limbs. The pelvic cavity is a body cavity that is bounded by the bones of the pelvis and which mainly contains the reproductive organs, the urinary bladder, the appendix, part of the large and straight intestine. The abdominal cavity contains the stomach, berry, liver, gallbladder, pancreas, small intestine and part of the large intestine. The abdominal cavity is not physically separated from the pelvic cavity and the cavities are often referred to collectively as the abdominopelvic cavity.

Blood loss internally in the abdominopelvic cavity often occurs with blunt trauma, or blast injuries, pelvic and abdominal fractures, or pelvic surgeries (eg, hysterectomy), which cause damage to the blood vessel network located on the inner wall of the abdomen. abdominal cavity and / or pelvic cavity. Up to 52% of patients with pelvic fractures had developed a hemorrhagic check in the emergency department. Containment of abdominal and pelvic haemorrhage has been limited to more stringent interventions, including pharmaceutical (eg recombinant Factor Vila), surgical (eg vascular ligation, such as hypogastric artery ligation) and radiological (eg selective arterial embolization). The pelvic cavity pack (eg Logothetopulos, mushroom or umbrella pack) has been used to control pelvic bleeding, but there is no commercially available product. Pelvic packaging is performed by the physician in situ using a sterile pouch (e.g., a trash bag, X-ray cassette, etc.) which is packed with gauze or other packaging material that can then be removed from the pouch. See, Dildly et al., An Effective Pressure Pack for Serious Pelvic Hemorrhage, Obstet. & Gynecol., 108 (5): 1222-1226 (2006). However, difficult-to-insert pelvic packaging cannot exert pressure where it is most needed (at the specific bleeding site or near the involved vasculature), and can mask continuous bleeding, making it difficult to determine if the bleeding was effectively contained by the bleeding. Pelvic pack.

Significant blood loss can also occur in gynecological and obstetric patients, for example due to trauma, abortion procedures, vaginal or cesarean delivery (eg, lacerations of the uterus, vagina or broad ligament or retained placental tissue). , or due to a variety of other causes, including premature placental abruption, placenta previa, right placenta or perceptual placenta or placenta, uterine atony, uterine inversion, coagulation disorders, chronic endometritis, and placental polyps. Treatments to manage gynecological / obstetric bleeding include: blood product (eg, blood or platelet transfusion) and / or pharmaceutical intervention (eg, Vila factor or other coagulation mediators, and uterotonics such as oxytocin , prostaglandins, misoprostol, methylergonovine, carboprost tromethamine, dinoprostone), uterine massage and compression sutures, surgical procedures (eg, iliac, hypogastric, uterine and / or ovarian artery ligation), and interventional radiology procedures (eg, selective arterial embolization). Hysterectomy is the last resort, especially if the patient is of low parity.

Uterine and vaginal packaging, similar to pelvic packaging, have been used to treat uterine and vaginal bleeding, but packaging for gynecological / obstetric bleeding has been largely replaced by the use of balloon catheters that were originally developed for other purposes. such as Foley catheters, Rusch catheters and Sengstaken Blakemore tubes. See, Bowen LW and Beeson, JH, Use of a Large Foley Catheter Balloon to Control Postpartum Hemorrhage Resulting from a Low Placental Implantation, J. Reprod. Med. 30: 623-628 (1985); Condous, GS et al., The Tampon Test in the Management of Massive Postpartum Hemorrhage, Obstet. and Gynecol. 1201 (4): 767-772 (2003). The Bakri SOS Balloon Buffer Catheter (manufactured by Cook Medical Inc., Bloomington, IN) is the only commercially available balloon catheter specifically designed to contain postpartum hemorrhage from an intact uterus. Bakri YN, Uterine tamponade drainage for hemorrhage secondary to placenta reviacrete, Jnt. J. Gynecol Obstet 27: 302 - 303 (1992), Bakri, YN, Balloon device for control of obstetric bleeding, Euro J. Obstet Gynecol. Playback Biol. 86: S84 (1999); Bakri YN, et al., Tamponade-balloon for obstetric bleeding, Int. J. Gynecol. Obstetrician 74: 139-122 (2001). Balloon plugging devices for vaginal and uterine bleeding center are described in US 4,552,557, US 5,062,425, US 5,571,153, US 5,674,239, US 6,024,753, US 6,520,977, US 6,676. 680; US 7,220,252; and patent application US 2006/0173486, US 2005/0049627, and US 2004/0030352.

However, there are disadvantages to existing balloon catheters used for uterine or vaginal bleeding. Existing balloon catheters are small in volume (total maximum 500 milliliters or less) and cannot be filled quickly (inflated with a fluid) because the elasticity of the balloon creates a counter inflation pressure that must first be overcome. For example, you need significant applied pressure to inflate a Bakri device, slowing down the full time inflation (the inflation needed to exert compression) by three minutes or more. In addition, when these balloon catheter devices are used to control uterine bleeding, external traction is applied to the bottom of the balloon device such that it remains at the base of the lower uterine segment. Bringing in balloon packing requires a means to prevent the balloon catheter from being pulled down into the vagina. Normally, the vagina is packaged separately (even if not bleeding) to prevent uterine balloon packing from being pulled by traction into the vagina, resulting in additional delay and rapid control of uterine bleeding. In addition, it is often desirable to simultaneously control bleeding in the uterus and vagina, but there is no unitary device to provide tamponade to both body cavities.

Due to the substantially larger volume of the abdominopelvic cavity, none of these existing vaginal or uterine balloon catheter devices is suitable for controlling bleeding in the pelvic or abdominal cavity. Therefore, there is a need for an effective means to control bleeding from an abdominal or pelvic cavity. There is also a need to control bleeding from an abdominal or pelvic cavity, which does not mask a continuous bleeding. In addition, there is a need for a bleeding control device that provides separate lumens for administering body cavity fluids and for draining body fluids and body cavity remnants. In addition, there is a need for an apparatus having the ability to simultaneously control bleeding from a uterus and a vaginal body cavity. There is also a need for an effective means to quickly control bleeding in a body cavity.

The present invention is directed to overcoming one or more of the problems presented above. The disclosed invention is not limited in any way by the descriptions or definitions, or the diagnostic or clinical indications or uses described herein.

Brief Description of the Invention The present invention relates to an apparatus (sometimes referred to herein as a "balloon plugging") for controlling bleeding in a body cavity and, unless otherwise indicated herein, "body cavity" it must mean a pelvic cavity, abdominal cavity, a uterus or a vagina. After the appliance is implanted or inserted into a pelvic cavity or abdominal cavity, the balloon is inflated to expand it into a shape within the body cavity. Expansion of the balloon is such that, in general, it fits as close to the shape of the body cavity as possible, causing a compressive or pressure force against the wall, tissue, structure or a bleeding site, and thereby controlling bleeding from the body cavity. The apparatus of the present invention may also be used as a prophylactic device in patients expected to undergo internal bleeding in a body cavity (e.g. due to trauma or surgery or other medical condition) such that the device is implanted. before bleeding begins and may prevent bleeding or limit the severity of the bleeding occurring.

Specifically, in one aspect of the present invention, and provided with a deformable and expandable material (referred to herein as a "balloon") and a conduit, the sealable balloon surrounds at least a portion of the conduit. The conduit has a first lumen (a first inflation lumen) in fluid communication with the interior of the balloon to provide a channel for inflating the balloon when it is implanted in a body cavity. The conduit is further comprised of a second lumen and a deformation means for deforming the shape of the balloon such that a balloon size is changed in one axis or one direction. Balloon deformation changes the balloon dimension in a first direction or axis causing expansion and compression forces are directed in a second preferred direction or axis. For example, the deformation of the balloon in the dome changes the shape of an ellipse on the longitudinal axis to an ellipse on the lateral axis, thereby directing expansion laterally on the posterior / anterior axis against the sides of the body cavity.

In still other preferred embodiments, the pelvic tamponade balloon conduit extends the length of the balloon and is sealably enclosed by the balloon at the distal and proximal ends of the balloon. The conduit comprises an inflation lumen and a second irrigation / drainage lumen. The irrigation / drainage lumen has a distal end and a proximal end and lumen openings at or near the distal and proximal opposite ends of the conduit in communication with the pelvic or abdominal cavity and the outside of the subject's body. , to provide fluids for (irrigation) and / or to receive fluids and debris (drain) from the pelvic or abdominal cavity. In another aspect, the tube may have separate irrigation and lumen drainage to minimize contamination of the body cavity that may occur when irrigation and drainage is performed through the same lumen. In still other embodiments, separate inflation lumens and deflation lumens may be provided, each lumen being in communication with the interior of the balloon, to allow circulation or replacement of the inflation media while maintaining a substantially continuous pressure within the balloon. which is preferred when heating or cooling of the body cavity is desired.

In yet another embodiment, the balloon apparatus provides a means for controlling bleeding from separate areas within the body cavity or from a body cavity and a natural or body-created lumen or orifice (e.g., a pelvic cavity and a vagina, or a pelvic cavity and a hole created in a perineum). In a preferred embodiment, the balloon apparatus comprises at least two axially spread buckets along the inflation tube, each balloon capable of being inflated to control bleeding from the separate areas. In other preferred embodiments, separate inflation lumens are provided such that the buckets may be separated and differentially inflated, or such that only one of such buckets may be inflated.

In other embodiments, the balloon apparatus may further comprise an introducer or guide to assist insertion and placement of the apparatus when the balloon is introduced through one or a lumen or channel into an individual (e.g. insertion through the vagina). of a female who has had a hysterectomy or insertion through an opening created in a male's perineum). However, other embodiments include a rigid bare semi-rigid collar located at the base of the balloon and provided to provide a means of bringing it into the apparatus, thereby preventing displacement of the balloon apparatus or upward movement of the balloon apparatus further into the cavity. of the body. In still other embodiments, the balloon apparatus may further include one or more connecting means (such as fittings, luers / leurs, adapters, etc.) for attaching a lumen of a balloon apparatus tube or conduit to the tubes and / or a source of means of inflation that is external to the body. In still other embodiments, the balloon apparatus may further include a control means for keeping the inflation medium within the balloon. Control means (e.g., valves, registers, clamps) may also be provided for sealing and non-sealing a lumen of a tube or for controlling inflow or flow through the lumen of the pipe, tubes or conduits of various embodiments of the present invention. . In still other embodiments, the balloon apparatus may further comprise a pressure detecting means, such as a pressure measurement, for detecting the internal pressure of the means within the balloon.

In another aspect of the present invention, there is provided a method for controlling bleeding from a pelvic or abdominal cavity by inserting or implanting an expandable balloon into a pelvic or abdominal cavity of a bleeding (or bleeding) individual. may suffer). Once implanted, the balloon is inflated with a physiologically and biologically compatible fluid and is maintained in its inflated state within the body cavity at a given pressure and for a period of time, as may be determined by clinical judgment to be sufficient for control. of bleeding. Preferably, the inflation pressure (internal pressure) of the balloon would be maintained at or just above the blood pressure of the subject. The inflated balloon apparatus may be maintained in the individual for any appropriate period of time, in most cases from about 20 minutes to 72 hours and preferably only as long as necessary to determine that the bleeding has been effectively controlled (evidence blood clotting and no bleeding from the body cavity, or other sign of hemostasis), or that the damage is so severe that the balloon apparatus cannot adequately center the bleeding, that such a more significant and required intervention (eg, a surgical or radiological intervention). The medical group can assess whether the bleeding was controlled or stopped by the release of the balloon inflation medium (by aspiration or the release or opening of a control medium).

In another aspect, the present invention provides a balloon buffering kit comprising a balloon apparatus, one or more inflation supply tubes, effluent drainage tubes, a fluid collection means and instructions for use and device deployment.

Other aspects, features, embodiments and advantages of the present invention will be apparent from the following specification, claims and figures.

Brief Description of the Figures The present invention will be better understood and novel features, details and advantages of the present invention will be more clearly disclosed with reference to the schematic figures illustrating the specific embodiments of the present invention by way of example only. not limiting.

Figure 1 illustrates a cross-sectional view of an uninflated embodiment of a balloon plug of the present invention.

Figure 2 illustrates an isometric elevation of an uninflated, folded or pleated balloon of the present invention.

Figure 3 illustrates a front elevation of an uninflated, folded or pleated balloon of the present invention.

Figure 4 illustrates a cross-sectional view of an inflated double balloon plug of the present invention.

Figure 5 illustrates an elevation of a double inflated balloon plug of the present invention.

Figures 6a, 6b, 6c, 6d, 6e and 6f illustrate cross-sectional views of conduits having lumen configurations suitable for various embodiments of the present invention.

Detailed Description of the Invention The following description includes a description of embodiments of the invention as currently known. The descriptions are in no way intended to limit the present invention and the examples are given for illustration only, so that by reference to the accompanying figures a person skilled in the art may consider the features, aspects and advantages of the present invention.

The present invention, for controlling a bleeding in the pelvic or abdominal cavity of an individual, comprises an expandable material! (e.g., a balloon), which is implanted into the body cavity and, when inflated by a fluid medium, generally suits the shape of the body cavity by exerting a compressive force against at least one wall, surface, structure or location (e.g. a bone, blood vessel, organ or tissue) to control bleeding from the body cavity. The various manifestations of the apparatus described herein are sometimes referred to as a "balloon tamponade" and / or "balloon apparatus".

When used herein with reference to a balloon, the following terms shall have the following meaning: "deflated" shall mean a condition of the balloon immediately before and after insertion, followed by "fill" indicating that the balloon has been inflated, then followed by drainage, wherein the inflation fluid is released such that the balloon returns to the deflated state (e.g., the condition of the balloon prior to removal under intended use conditions); “Deforming” shall mean a feature or attribute of a balloon that allows the balloon format to be altered when desired; “Conforming” shall mean a condition of a balloon in which the balloon has changed shape to substantially mirror that of the implantation site; “Compliance” shall mean a characteristic or attribute of a balloon that allows the balloon to change shape to substantially mirror that of the implant site in response to a resistive force within the body cavity (for example, due to a wall, structure or tissue or organ) or in response to a pull or other force applied to the balloon.

Referring now to the figures, wherein like numerals designate like and corresponding parts in all the various views, in Fig. 1 a balloon plugging apparatus 200 for controlling a bleed in a body cavity is shown. pelvic or abdominal area comprising an expandable material! (balloon) 100 having a distal end 190 (with referent placement, a cephalic end) and a proximal end 180 (with referent placement, a caudal end), and a conduit 30 having an inflation lumen 32 at communicating with the interior 50 of the balloon through one or a plurality of openings 34. The inflation lumen provides a means for inflating or filling the interior of the balloon with a fluid medium (e.g., a gas or liquid), thereby expanding the balloon in a shape within the body cavity. The inflation lumen also provides a means for deflating the balloon by flowing or withdrawing the inflation medium from the balloon such that the apparatus may be removed from an individual's body cavity. Preferably at least a portion of the tube is sealably wrapped by the balloon, the seal providing a means for maintaining the inflation medium within the balloon and for securing the tube to the balloon.

The balloon is made from an expandable material such as natural rubber, synthetic rubber, silicone, latex, urethane (polyurethane), polyvinyl chloride, polyethylene, nylon or any other expandable elastomer, polymer or other material. Preferably, the balloon is formed of sterilizable bi compatible material which is ultrasonic / radiopaque and may be treated with antimicrobial agents. Most preferably, the balloon will have sufficient compliance to generally conform to the shape, contours, walls and structures of a pelvic or abdominal cavity. However, it should be appreciated by a person skilled in the art that under certain circumstances it may be preferable to have a balloon that is non-resilient and / or non-conforming and which will generally retain its original shape after inflation. In a preferred embodiment shown in Figure 5, a vaginal balloon 150 having a cylindrical or oval shape will be non-conforming such that the vaginal balloon retains the cylindrical or ovoid shape when inflated within a vagina.

Balloons of various embodiments of the present invention may be of any shape, contour, size and volume. Preferably the shape, contour, size and volume and such that, when inflated, the balloon will generally suit the body cavity where bleeding is to be controlled (i.e. the inner wall or surface or structure of the pelvis or abdominal cavity). ). Most preferably, the balloon will be substantially suited to the body cavity. Compliance of the external shape of the balloon with the wall, surface or internal structure of the body cavity allows the balloon to fit against a wall, surface or structure thereby exerting a compressive or pressure force to control bleeding. The balloon may have folds, ribs, channels, undulations and / or other formations or contours to increase the expandable surface area! of the balloon, or to facilitate expansion in a desired manner, or to facilitate compliance of the balloon with an internal surface, or to enhance balloon compliance to accommodate the specific features, structures, tissues or organs of the body cavity. As shown in Figs. 2 and 3, the balloon may comprise a plurality of folds or folds to facilitate rapid inflation or inflation in the "full volume" of the balloon, overcoming the elasticity of the expandable material. Particularly suitable forms for the pelvic and abdominal cavity include spherical, mushroom-shaped, tear-shaped, heart-shaped or winged, ovoid, oblong, and cylindrical cavities. The balloons of the present invention may be produced by any conventional method known in the art, such as by extrusion or dip molding.

The balloon is constructed to be inflated by and maintain a biologically and physiologically compatible medium, preferably a fluid and more preferably a liquid, such as water or saline, or any other liquid used for infusion. intravenous, such as Ringer's, lactated Ringer's, sterile water for injection, or sterile saline. The size and volume of the balloon will be determined by the body cavity or selected area of a body cavity where bleeding control is desired. Balloons can be of any size or volume. Preferably, balloon packings suitable for the pelvic and abdominal cavities may be inflated or filled with fluid volumes between about 500 milliliters and about 5 liters, while balloon packings suitable for a uterine or vaginal cavity may be about from 200 milliliters to about 1 free. If bleeding is known to originate from a specific area of a body cavity, a smaller size and volume balloon appropriate for the selected area may be used to locate pressure in the body cavity selection area. In addition, male and female anatomy and individual size (eg, adult versus child) may dictate balloon shapes, contours, sizes and volumes that are suitable for controlling bleeding from an individual's body cavity. . For example, a child's balloon plugging may require a balloon volume capacity of about 500 milliliters to about 1 liter, while a large male adult balloon plugging may require a balloon of about 3.5 liters to about 1 liter. about 5 liters.

In certain preferred embodiments, a balloon suitable for a pelvic or abdominal or uterine cavity may be of a size having 400 milliliters of neutral (non-inflated) inflation, and 1 free in the total filled volume when inflated. More preferably, a balloon suitable for a pelvic or abdominal or uterine cavity may be of a size 5 having 800 milliliters of neutral inflation and 1.5 liters of total filling volume when inflated. The creep force (application of internal balloon down means) should be no more than 10 N when inflated to full fill volume pressure, most preferably not greater than 3 N when inflated to full fill volume pressure . Most preferably, the diameter of the balloon prior to insertion (in the non-inflated state) will not exceed 3 centimeters, preferably not more than 1 centimeter. The balloon diameter at deflation (removal diameter) is preferably not more than 4 centimeters, and most preferably not more than 2 centimeters. In certain preferred embodiments, a balloon suitable for a vaginal cavity may be of a size with a diameter of 10 centimeters and a length of 20 centimeters when fully inflated, preferably a diameter of 12 centimeters, and a length of 25 centimeters when fully inflated. inflated.

The tubes, pipes or conduits of the balloon buffering apparatus and various aspects, features and embodiments of the present invention may be made from any bi compatible material such as natural rubber, synthetic rubber, silicone, latex, polyurethane. (polyurethane), polyvinyl chloride, polyethylene (eg, low density polyethylene), nylon, polycarbonate or any other flexible and compatible bi-elastomer, polymer or other material suitable for tubes, conduits, tubing and catheters. However, it should be recognized by the person skilled in the art that, under certain circumstances, it may be preferable to have a conduit (or part of a conduit) that is less flexible or inflexible, rigid or semi-rigid (non-resistant and / or non-compliant). ), such as a part of a conduit contained in a vaginal balloon. Preferably, the tube, conduit or tubing is formed of a sterilizable material that is ultrasonic / radiopaque and may be treated with antimicrobial agents. Most preferably, the tube, conduit or tubing is made of polyethylene, silicone or nylon. As used herein, the conduit may comprise a single tube having a single lumen, multiple tubes each having one or more lumens, a tube within a tube and each pipe having one or more lumens, or an extruded conduit having a plurality of lumens within the extruded conduit, in each case having lumen diameters, lumen lengths and openings as appropriate for the particular lumen purpose. The “working length” of a lumen (ie the length needed to perform its function) can be changed by clogging or trimming the individual lumen to achieve the desired length to obtain or perform a specific function. For example, lumen drainage and irrigation extend beyond the distal and proximal ends of the balloon, such that each lumen, as may be in communication with a body cavity at or near the distal end of a balloon, and at the proximal end be in communication with the outside of the subject's body. An inflation lumen cannot extend the length of the balloon at the distal end, but may extend beyond the proximal end and have an opening in communication with the outside of the subject's body for connection to a source of inflation medium.

As described in more detail below, the tube or conduit or tube of various embodiments of the present invention may comprise one or a plurality of lumens, the lumens having one or a plurality of openings for fluid communication with the interior of the balloon or a lumen. or a separate tube or conduit or body cavity.

As shown in the Figure. 6a-g, lumens may be provided in any arrangement suitable for a particular embodiment of the present invention described herein. Fig. 6a and 6b illustrate a single tube having two lumens, Fig. 6 c and 6d illustrate a single tube having three lumens, Figs. 6e and 6f illustrate a single four lumen tube. Balloon cap tubes and conduits, and in particular those tubes and conduits that are physically contained within or surrounded by the balloon, are preferably sufficiently inflexible or rigid or inelastic to maintain their internal diameter when the balloon is inflated. (eg made from a stiffer / inelastic material than the balloon or has a thicker cross section than the balloon wall). The inflation lumen must be large enough in diameter to allow rapid inflation or balloon inflation. Preferably, the inflation lumen will be of a diameter to allow inflation or inflation of the balloon in about three minutes or less, and more preferably in one minute or less. Inflation supply may be provided to inflate the balloon, such as a large syringe, a pump (e.g., an infusion pump), an IV fluid-filled source (e.g., a bag or bottle) or other container to center the fluid, preferably a sterile sealed container readily available to the center medical group or to provide a physiological fluid.

As shown in Figure 4, in another aspect, the present invention provides a deformation means for deforming the balloon shape or limiting balloon expansion in a first direction, so that when the balloon is inflated, more force and exerted in a second direction against the wall or surface or structure (for example, a bone, a blood vessel, an organ or tissue) within the body cavity to control bleeding. The deformation means may be any means suitable for limiting the expansion of an expandable material or for exerting a deformation force resistive or counteracting the expansion of a balloon wall during balloon inflation or for altering the size of a balloon or altering the shape of a balloon. For example, in a preferred embodiment, as shown in Figure 4, the bringing means 115 (e.g., a wire, cable, filament or other bringing accessory) are connected by a pulling connection means (e.g. , a lake, an adhesive, a fitting, etc.) 110 to a wall at the distal end 190 of the balloon and extend the length of the balloon to a bring-down means 120 such as a guide, a support, a ring, a ratchet, clamp, friction wheel, ball or step catch, or other locking or locking means or other means for applying a pulling force to the pulling means. Applying a down force (eg, pulling down) on the down means during inflation (or after inflation) will deform the balloon's expandable shape, limit the upward expansion of the balloon and cause a more lateral expansion of the balloon, thereby selectively causing lateral and downward pressure along the sides and base of the body cavity. Alternatively, a draw wire, cable, filaments or other draw or tensioning means may be attached (fixed or loose) to a portion of conduit 30 or an inner sheath 130 around the conduit at the proximal (caudal) end of the conduit. or near the balloon, which provides a drag force during inflation to deform the shape of the balloon or limit the upward expansion of the dome (distal / cephalic end) of the balloon. Alternatively, the deformation means may be an area or wall of expandable material having less expandability or elasticity than another area or wall of the balloon, thereby deforming the balloon shape or limiting balloon expansion in that area. For example, the deformation means may be a cap or disk within a balloon wall, or a collar (rigid or semi-rigid) disposed on a balloon wall or area. In yet another embodiment, the deformation means may be a second balloon which, when inflated or filled, provides a resisting force against expansion of the first balloon.

In yet another embodiment, the bringing means may be the balloon sheath disposed (laminated) within the balloon during assembly to effectively position the sheath approximately at the midline portion of the conduit enclosed within the balloon, wherein the conduit provided in this way becomes a means of bringing the. When tension is applied to the duct, the proximal end of the balloon "rolls" over the sheath, deforming the balloon shape to more elliptical on the lateral or horizontal axis than the longitudinal axis, and forcing the proximal end of the balloon to conform to the surrounding anatomy of the body cavity.

In yet another embodiment, a balloon may be comprised of an expandable material! which increases in thickness in an area of the balloon wall, thereby limiting the expandability of the balloon to the thicker wall, deforming the shape of the balloon and causing the balloon to be directed to areas where the balloon wall is of the lowest thickness. or greater expandability. Most preferably, the thickened area in the is at the distal or cephalic end of the balloon, so that expansion is limited at the cephalic end or cephalic-caudal axis, thereby facilitating balloon expansion laterally (dorsal axis) and anterior axis. (front) and posterior (back).

As shown in Figures 5 and 6, in yet another embodiment of the present invention, the balloon buffering apparatus comprises an expandable balloon and a conduit, a conduit 30 comprising an inflation lumen 32 in communication with the interior of the balloon. and a drainage / irrigation lumen 70 extending beyond the distal (cephalic) end of the balloon and having a distal opening 72 in communication with a pelvic or abdominal cavity and a proximal opening 76 in communication with the exterior of the subject's body. Preferably, the distal and proximal openings are located on or near opposite sides of the drainage / irrigation lumen. The drainage / irrigation lumen provides a means for draining the body cavity (eg, blood, debris and irrigation fluids) and for irrigating the body cavity with cleansing and hydrating fluids (eg water or saline) and therapeutic agents (e.g. pharmaceuticals) or diagnostic instruments. In an alternative embodiment, as shown in Figure 6c-g, the balloon buffering apparatus provides a separate irrigation 72 and drainage lumen 74 to minimize contamination of the body cavity (e.g. due to debris returning to the cavity). during irrigation fluid supply). Preferably, the proximal end of the conduit comprising the drainage / irrigation lumen (if a single lumen or separate lumens) extends outside the body to facilitate irrigation and collection of drainage material. Preferably, the lumen drainage is of sufficient diameter to permit the removal (by washing or aspiration) of debris (tissue fragments, cells, blood clots) that may enter the drainage tube, and to prevent such debris from blocking the debris. drainage of liquids through the drainage lumen.

In a preferred embodiment, as shown in Figure 5, the tamponade balloon comprises a conduit assembly having a distal end and a proximal end, a first balloon 100 and a second balloon 150 coaxially spaced along the conduit, wherein the conduit is sealably enclosed by each of the first balloon and second balloon and comprises a first inflation lumen (40 as shown in Figure 6g), in communication with the interior of the first balloon and a second inflation lumen. (42 as shown in Figure 6g) in communication with the interior of the second balloon. The first balloon has at least one fold or crease to facilitate rapid inflation and inflation and is axially spread along the conduit adjacent the distal end of the conduit. The second balloon is cylindrical in shape and is non-compliant to substantially maintain the cylindrical shape in inflation. In the conduit assembly, the second conduit is slidably disposed over the first conduit and the conduit assembly comprises the lumen configuration shown in Figure 6g. The second conduit has a joint disposed between the first and second balloon, wherein the joint is comprised of a joint socket to allow the second balloon to be dissociated from the first balloon in the joint. The joint may be a friction unit, a quick fit, a screw fit, a cone fit, a collar, a bayonet fitting, or a quick release fitting.

In yet other embodiments, the balloon apparatus may further include one or more connecting means for connecting a lumen of a conduit to a lumen of a tube or a medium source (e.g., irrigation fluid or inflation means). ), or to a drainage container, or to control means or pressure holding means (as described below) that is located outside the body. Any conventional connecting means may be employed, such as luers / leurs, algae, latches, locknuts, rings, fittings, Y-connectors, adapters, connecting means described in US 6,520,977 (which is incorporated herein), and any other suitable means for connecting pipes, conduits, piping or control means. Connection means for use in medical applications are commercially available and are well known in the art. Preferably, where an IV pouch is the inflation supply source, the connecting means for connecting an inflation lumen at the inflation supply source and a sharp pouch for puncturing an IV pouch to facilitate rapid balloon filling.

In other embodiments, a control means is provided for sealing or opening, or maintaining or releasing, or regulating fluid flow through the lumen of the tubes, conduits and tubing of the present invention. The control means may be any suitable means for sealing or opening, or regulating flow through a lumen, or for controlling inflow or flow through the lumen or for retaining or releasing a fluid within a lumen. The control means may include flow volume regulators, valves (e.g. ball valves or needle valves), registers, closures, clamps (eg pliers, hole punch, slide and roller closures), clamps, lids, stoppers, lids and any other suitable means for sealing or opening a pipe or conduit or pipe. Such control means for use in medical applications are commercially available and known in the art. Preferably, the control means for irrigating pipes or lumens has a means for providing flow in one direction (e.g., one way valves) to prevent reverse flow. Control of means for lumen deflation or lumen drainage preferably comprises a one-way register.

In still other embodiments, balloon plugging may further comprise a means for detecting the pressure level within the balloon, such as a simple pressure gauge. The pressure sensing means may be connected by the connecting means in the inflation lumen. During balloon inflation, the pressure measuring needle will pulse in conjunction with the individual's heartbeat. When the balloon is inflated with sufficient pressure (ie at or just above the individual's blood pressure), the pressure measuring needle will stop pulsating.

In other embodiments, as shown in Figure 5, the balloon plugging apparatus may further comprise an external pull connection means 175 for mounting an external pull source 300 to apply external pull to the apparatus. balloon buffering after inflation has been completed. The external pull source 300 can be any means of applying a pull force in the caudal direction, such as by manually pulling, attaching a weight or a full IV bag / bottle, or tying a draw line to the draw leg. an individual. Bringing the outside into balloon packing provides yet another means for applying the compression force caudally toward the base of the body cavity. The external bring down source 300 is connected to the external bring down connection means 175 (fixed or loose) by means of a connecting means 185, such as a thread, filament or rope. Preferably, the external drag connecting means 175 comprises a semi-rigid sheath or a rigid sheath having a securing means for securing an external drag connecting means to the sheath. The sheath may be sealably or removably attached to a balloon plug conduit, preferably at or adjacent to the proximal end of the conduit.

In certain embodiments of the balloon tamponade, the apparatus may further comprise an introducer assembly to assist in the insertion of the balloon tamponade into a pelvic or abdominal cavity of an opening in the body (for example, in a hysterectomy patient through vagina, or in a male patient through a perineal incision). The introducer assembly is generally used to prevent the balloon plugging device from flexing excessively during insertion. The introducer assembly comprises a wire attached to a surrounding medium at a proximal end. The wire is passed from the proximal end to the distal end of a duct lumen and substantially extends the length of the balloon. Preferably, the introducer wire is passed through a lumen not in communication with a body cavity (e.g., not passed through an irrigation lumen or drainage lumen). Preferably, the introducer assembly wire extends within one or two centimeters of the distal end of the lumen.

Generally, the introducer assembly is removed from the balloon plug lumen after balloon plug insertion and positioning in the body cavity was performed. The wire may comprise an exchange, guide, rod, stylus or other semi-rigid or rigid means to assist in the insertion of a medical tubular device (e.g., a catheter) into an individual. The downing wire described above may also function as an introducer in certain embodiments of the present invention. In an alternative embodiment, the introducer may be surrounded by a drainage pipe or an irrigation pipe. The insertion means may be hollow or solid and may consist of any suitable material that will not damage the balloon or body cavity or the organs or tissues of the individual, such as natural or synthetic rubber, latex, semi-rigid polymers (e.g. , polyethylene or polyvinyl chloride or polycarbonate), or metal.

In other embodiments, an external surface of the balloon may be coated (e.g., by layer, film, spray, gel or powder), impregnated, infused, impregnated or comprise a hemostatic material or a pharmaceutical composition, such that The hemostatic material or composition may come into full contact with a wall, tissue or structure within the body cavity. Any pharmaceutical product may be used, and hemostatic agents such as oxidized cellulose, haemoptic, thrombin, factor VII, and blood clotting factors are particularly suitable for use in conjunction with balloon buffering.

In a preferred embodiment shown in Figure 5, the balloon buffering apparatus comprises a first balloon having a distal end and a proximal end, sealably around a portion of a first conduit having a first lumen and in communication. with the inside of the first balloon. At the proximal end of the balloon, the balloon meets an outside of the first tube in an inner sheath 130. The first conduit extends outside the body 250 and is connected to a control means for maintaining the balloon in an inflated state and for releasing fluid in a controlled manner (deflation) from the balloon when pressure in the body cavity is to be reduced or when the device is to be removed from the body cavity.

In a preferred embodiment, a balloon plug is provided for controlling bleeding in an individual's body cavity, comprising an expandable balloon comprising a plurality of folds or folds, and having a distal end and a proximal end. The device further comprises a sealed conduit surrounded by the balloon, having a distal end and a proximal end and having an inflation lumen, a guide lumen, an irrigation lumen and a drainage lumen. The bringing means (preferably a wire or cable) extends the length of the guide lumen. Bridging attachment means, preferably a sheath, is disposed along or near the proximal end of the conduit. The inflation lumen is in communication with the interior of the balloon and the guide lumen is in communication with an inner surface of the distal end of the balloon. The irrigation and drainage lumen are each in communication with a body cavity through the openings at or near the distal end of the conduit and are each in communication with the outside of the subject's body through the opening of the proximal end of the conduit. conduit or near it. Downing means are attached to the inner surface of the balloon at the distal end of the balloon and are attached to the downing connection means (e.g., sheaths) at the proximal end of the duct.

In yet another embodiment, a double-capped balloon for controlling bleeding in a body cavity comprises a first balloon and a second balloon, each with a distal end and a proximal end. The first balloon comprises a plurality of folds or folds. A first conduit having a distal end and a proximal end comprises a first inflation lumen in communication with the interior of the first balloon, and is sealed and surrounded by the first balloon. A second conduit has a distal and proximal end and comprises a second inflation lumen in communication with the interior of the second balloon. The second conduit is sealed and surrounded by the second balloon and the second conduit is slidably arranged over the first conduit. A first semi-rigid sheath disposed between the first and second balloon surrounds either the proximal end of the first balloon or the distal end of the second conduit. In other embodiments, the first conduit further comprises an irrigation lumen and a drainage lumen, each of the irrigation lumen and the drainage lumen having an aperture communicating with a body cavity and an aperture communicating with the exterior of the body. individual, to provide channels for irrigation and drainage of the body cavity. The engaging means may be provided for releasably engaging the second conduit with respect to the first conduit. Such locking means may include a friction unit, a quick fit, a screw fitting, a cone fitting, a collar, a bayonet fitting or a quick release fitting.

Fig. 6a illustrates yet another embodiment, wherein the inflation lumen may comprise a bifurcated lumen 32a and 32b, and each of these bifurcated lumens may be attached to the control means, thereby allowing simultaneous infusion / inflation. draining a physiological medium from inside the balloon, or allowing the physiological medium within the balloon to be changed as needed (for example, to allow fluid replacement) without changing the pressure within the balloon. Bifurcation of the inflation lumen also allows substantially continuous circulation of a physiological medium into and out of the balloon, as when heating or cooling of the body cavity is desired. In a preferred embodiment, an additional tube provides flow inlet and outlet means of a physiological medium capable of being heated or cooled, thereby providing a means for heating or cooling the physiological medium within the balloon, where said tube may constitute a medium. or more lumens in an open or closed circuit configuration, with or without external tube exchange. Specifically, a cycle may be created from a tube such that the diameter is compatible with current peristaltic or infusion pumps, or others, and with heat or cooling sources, such that liquid within the balloon (s) It may be circulated in a closed cycle by the pump through a heat or cooling source in order to increase or decrease the body cavity temperature.

In another aspect, the present invention provides a quick fill balloon for controlling bleeding in a body cavity comprising an expandable balloon! with a plurality of folds or folds. The balloon has a fluid fill volume (volume in total inflation) of between 300 and 1,000 milliliters, and is capable of being inflated to fill the volume in less than three minutes without the need to apply pressure to overcome balloon elasticity.

In another aspect of the present invention, there is provided a kit for controlling bleeding in a pelvic or abdominal cavity comprising an embodiment of the expandable balloon plugging apparatus. described herein, and the instructions for use of such materials, and the package containing the balloon plugging apparatus and the instructions. In another preferred embodiment, the balloon buffering kit further comprises a drainage container and a connecting means for releasably connecting the drainage lumen to the drainage container to collect the fluids and debris that are discharged from the drainage lumen. drainage. In still other embodiments, the kit may further comprise inflation supply tubing and / or irrigation supply tubing and / or drainage flow tubing, or any combination thereof, together with suitable connection means for connection. such inflation supplies, irrigation supply or drainage flow tubing in the balloon buffering apparatus. In certain preferred embodiments, the kit may further comprise a pharmaceutical agent, such as a hemostatic agent that may be applied to the balloon surface prior to implantation. The kit may further comprise digital or electronic information and instructions for use, insertion and deployment of balloon buffering devices such as a video cassette, compact disc (CD), digital video disc (DVD), flash or zip or thumb drive, or any other means for electronically storing information that can be accessed through a computer.

[0052] Another aspect of the present invention provides a method for controlling bleeding in a body cavity by providing balloon packing in an unfilled (unfilled) state, implanting or inserting balloon packing in a body cavity ( with or without the assistance of an introducer), fill the balloon with a biologically and physiologically compatible fluid through the tube inflation lumen (preferably a sterile heated or cooled fluid) supplied from an inflation medium supply source. such as a full IV pouch or a syringe with the means of inflation. The physiological medium is supplied at a pressure and volume sufficient to inflate the balloon (or the particular balloon of a double balloon plug, as appropriate). During the infusion of the physiological medium, the balloon dilates and its effect on bleeding is observed by flow from a drainage tube. Preferably, the effluent is collected for measurement and evaluation. The preferred inflation pressure of the balloon is the lowest pressure that controls bleeding from the specific body cavity into which it is placed, and most preferably, the pressure that stops bleeding from the individual's body cavity.

When the desired volume or pressure is reached within the balloon, the control means may be manipulated to cease further infusion of the inflation medium and / or to maintain the inflation medium within the balloon and the lumen of the balloon. inflation. The external medium source is turned off, and a drainage bag or other drainage collection vessels can be releasably connected by the connection means in the drainage lumen (or in a drainage flow pipe connected to the drainage pipe through connection means) to capture drainage fluid. Optimal pressure is detected, for example, when fluid is no longer draining from the drainage tube, or when blood clots are observed in the drainage tube, indicating that normal coagulation has been restored in the individual. After a suitable period of time, the balloon pressure may be reduced (fluid gradually drained or released from the balloon through the inflation or deflation lumen as applicable) and observations made to determine if bleeding was controlled (i.e. , if bleeding was observed in the drainage tube). If bleeding is observed on the release of balloon pressure, then the balloon may be inflated again to an appropriate pressure to control bleeding.

These and other aspects, features and advantages of the present invention are apparent from the Detailed Description of the Invention when obtained in conjunction with the figures. In addition to the objects, features and advantages in the embodiments and examples described above, other objects, features and advantages of the present invention will be apparent to those skilled in the art. The described aspects are merely illustrative of the numerous aspects related to the present invention and should not be construed as limiting in any way. While methods and material similar or equivalent to those described herein may be used in the practice of the present invention, appropriate methods and material are described above. The materials, methods and examples are illustrative only and are not intended to be limiting in any way. While preferred examples and steps of the present invention have been described and illustrated, this has been performed by way of example, the present invention should not be limited except as required by the scope of the appended claims and their equivalents.

Claims

Claims (19)

1. DEVICE (200) FOR CONTROLING GYNECOLOGICAL AND OBSTETRIC HEMORRAGY IN A PATIENT BODY CAVITY, characterized in that it comprises: a first expandable balloon (100) adapted to be inserted into a uterine cavity and capable of being filled with a liquid in a volume between 200 milliliters and 1 liter, wherein the outer geometry of the first expandable balloon (100) is adapted to conform to the internal area of the uterine cavity; and a second expandable balloon (150) adapted to be inserted into a vaginal cavity and capable of being filled with fluid in a volume between 200 milliliters and 1 liter, coaxially spaced along a conduit (30) from the first expandable balloon (100), wherein the conduit (30) comprises a distal end and a proximal end, the conduit (30) being sealably wrapped by the first expandable balloon (100) and the second expandable balloon (150), and comprises : a first inflation lumen (32) communicating with the interior of the first an expandable balloon (100); and a second inflation lumen (74) communicating with the interior of the second expandable balloon (150). DEVICE (200) according to claim 1, characterized in that it comprises a bag spike nail configured to directly connect a liquid carrier bag to the at least one inflation lumen (32). DEVICE (200) according to any one of claims 1 and 2, characterized in that it comprises a deformation means configured to deform the shape of at least one expandable balloon (100,150) by inhibiting expansion in at least one. first direction and facilitating in at least one second direction, different from the first direction. DEVICE (200) according to any one of claims 1 to 3, characterized in that the conduit (30) comprises at least one first lumen (70, 72, 74, 42) in addition to the first inflation lumen. (32, 40), the lumen additionally comprising an opening near or at the distal end of the conduit (30) for communicating with the body cavity and an opening near the or near the proximal end of the first conduit (30) for communication with the external region of a patient's body. DEVICE (200) according to claim 4, characterized in that the first lumen (70, 71, 74, 42) is configured to perform drainage. DEVICE (200) according to claim 1, characterized in that it further comprises a deflation lumen (74), the deflation lumen (74) communicating with at least one expandable balloon (100). 150) to allow replacement or circulation of a fill liquid within the device (200). DEVICE (200) according to any one of claims 1 to 6, characterized in that it comprises a traction means (115) configured to provide a force towards the proximal end (180) of the device (200). DEVICE (200) according to any one of claims 1 to 7, characterized in that the first expandable balloon (100) comprises a liquid fill volume of between 300 milliliters and 1 liter and is capable of being inflated to a maximum. fill volume in less than three minutes without the need to apply pressure to overcome balloon elasticity. DEVICE (200) according to any one of claims 1 to 8, characterized in that the first conduit (30) comprises a socket arranged between the first expandable balloon (100) and the second expandable balloon (150); wherein the socket is defined by a locking joint configured to enable dissociation of the second expandable balloon (150) from the first expandable balloon (100). DEVICE (200) according to any one of claims 1 to 9, characterized in that it comprises a gauge or pressure sensor configured to detect the internal pressure of an inflation fluid within the first or second expandable balloon (100; 150). DEVICE (200) according to any one of claims 1 to 10, characterized in that an external surface of the first or second expandable balloon (100, 150) is coated, impregnated, infused, permeated or otherwise includes one or both of a hemostatic material or pharmaceutical composition for contact with a wall, tissue or structure within the body cavity when implanted. DEVICE (200) according to any one of claims 1 to 16, characterized in that the at least one expandable balloon (100, 150) includes at least one fold or ruffle configured to facilitate balloon inflation. DEVICE (200) according to any one of claims 1 to 12, characterized in that the first or second expandable balloon (100, 150) is capable of being inflated to a volume between 300 milliliters and 1000 milliliters without requirement. applying pressure to overcome the elasticity of at least one expandable balloon (100, 150). DEVICE (200) according to claim 1, characterized in that the first expandable balloon (100) is capable of being inflated to a volume of between 300 milliliters and 1000 milliliters in three minutes or less, filling the volume of the first one. said uterine cavity. DEVICE (200) according to claim 14, characterized in that the conduit (30) comprises a socket arranged between the first expandable balloon (100) and the second expandable balloon (150), wherein the socket is defined by a clamping joint configured to disassociate the second expandable balloon (150) from the first expandable balloon (100). DEVICE (200) according to claim 14, characterized in that the first expandable balloon (100) is conformable and the second balloon (150) is non-conforming to the internal area of a uterine cavity. DEVICE (200) according to claim 14, characterized in that the first balloon (100) is composed of polyurethane. DEVICE (200) according to claim 1, characterized in that the conduit (30) is sealably wrapped by the first and second expandable balloons (100, 150), wherein the first and second expandable balloons ( 100, 150) are inflatable to an expanded fluid volume by three minutes or less by filling a fluid volume from an IV pouch, wherein the IV pouch comprises a bag spike nail for ease of use. Quick fill of the balloons. KIT, characterized in that it comprises: a device (200) as defined in one of claims 1 to 18; and the device usage instruction series (200).